上海二类医疗器械备案必须要实际经营地址吗?
二类医疗器械备案申请材料:
1.《上海市第二类医疗器械经营备案申请表》
2.企业营业执照(分支机构需同时提交总公司营业执照)
3.自有/租赁:房屋产权证明文件或者租赁协议(附房屋产权证明文件)复印件
4.经营场所、库房地址:①地理位置图(网络地图截取);②外部幢号、楼层等布局图,内部平面图(标识温控区域、功能区域、人流物流方向、使用面积等);③设施、设备目录
5.人员:①法定代表人、企业负责人的身份证明;质量负责人身份证明、学历、职称、简历;②企业组织机构图(注明各岗位与人员姓名);③企业员工花名册,部门设置说明。
二类医疗器械包含常见的普通诊察器械类:体温计、血压计等,疫情期间医疗器械销售额突破天际,之前的销售医疗器械企业都是赚了一大笔,由于现在疫情反反复复办理医疗器械备案还是可以接到很多的项目来做的。
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营业执照地址和经营场所可以不一致吗?
二类可以的,医疗器械的经营场所可以和住所不一致,仓库也可以和经营场地分开。三类必须要完全一致